The current categorical approach used in Subpart C to review proposals for research involving prisoners is dependent on narrowly defined stipulated research categories that are subject to various interpretations. If a protocol does not fit a category, it is not allowed. This approach does not provide sufficient or reliable protections for the human subject because it does not consider the potential benefits and risks involved in the study and might disallow research that would be quite acceptable on risk-benefit grounds. In addition, the present structure does not address the actual conditions of confinement or the restrictions on liberty experienced by the prisoner subject (whether incarcerated or subject to restraints on liberty in connection with community-based alternatives to incarceration).
Recommendation: Apply a risk-benefit framework to research review. The Department of Health and Human Services should revise regulations regarding research with prisoners from a model based on categories to a system based on weighing of risks and benefits for the individual human subject, similar to the approach currently used in Subpart D. (Recommendation 5.1)
A risk-based approach is preferable because it requires human research participant protection programs (HRPPPs) and OHRP to (1) focus on the potential benefits and harms of each suggested research protocol, and (2) identify the particular ethical issues that each protocol raises in the specific context of the correctional setting. As in Subpart D (45 C.F.R. § 46.407), protections should increase as the risk-benefit scale tilts more toward risk (IOM, 2004).
A risk-benefit approach should apply to all types of research: biomedical, social/behavioral, and epidemiological. Ethically permissible research must offer potential benefits to prisoners that outweigh the risks. Under this framework, it is clear that studies offering no potential benefit to subjects would be precluded (i.e., testing of cosmetic products). Biomedical research in correctional settings would be severely limited. Phase 1 and 2 studies, as defined by the Food and Drug Administration (FDA), for example, would not be allowable because safety and efficacy are not yet clear in these early phases of biomedical research; therefore, risk would overshadow potential benefit.
Biomedical research involving prisoners in two narrow circumstances may be ethically acceptable:
In normal circumstances, a biomedical research study may be ethically acceptable if: